The present invention relates to a process for management of batches of components of the haematopoietic system, particularly lymphocytes, monocytes, marrow, serum, plasma, for deferred use. It also relates to a management system for using the process according to the invention.
Scientific and clinical works have demonstrated the therapeutic qualities of auto-use of lymphocyte and monocyte derivatives which helps, in particular, to increase cell immunity.
A promising application of this therapeutic method relates to the possibility of strengthening the immunity of a patient at a time in his life when this strengthening proves to be necessary or vital, or to maintain this immunity throughout his life.
However, a significant difficulty to be overcome lies in the availability of haematopoietic-system components of a patient over periods of time which could be between several months and several decades. Techniques of cryogenic storage for the future which are widely used in several fields of human and animal biology are already known. In particular, banks have been established for preservation and storage of biological elements.
Nevertheless, the current infrastructures and methods regarding storage and management of biological batches are not suitable for the specific application of auto-injection deferred in the long term.
The object of the present invention is to remedy these disadvantages by proposing a process for management of batches of haematopoietic-system components collected and preserved for deferred use, which gives the users a guarantee of storage and availability in the long term. This object is achieved by a process for management of batches of haematopoietic-system components belonging to human subjects from whom these batches have been collected for deferred use.
According to the invention, each batch of haematopoietic-system components associated with a subject is packed and stored in a cryogenic storage site among a plurality of cryogenic storage sites and then transferred on request from this storage site to a cell treatment center for re-use on said subject or on said subject""s parent, and a gathering of both personal data relating to the subject from whom the batch was collected and of data relating to the collection is associated with each collecting phase.
Such a process thus provides patients with the guarantee of storage of their lymphocytes in the long term, with the prospect of having them available at any time for, inter alia, strengthening of their immune system. It therefore becomes possible to give back to people their former immunity and to transmit a cell immunity under rational and reliable management conditions, and also to have access to their corresponding genetic code at the time of collection of the blood.
Preferably, at the end of a collection phase, the lymphocytes collected are packed in the form of a plurality of batches of lymphocytes. This allows flexible and efficient management of re-injections, without the fear of having to thaw a batch of lymphocytes in an excess amount with respect to the needs at that point in time.
In an advantageous embodiment of the process according to the invention, the batches of haematopoietic-system components are stored in several geographically distinct cryogenic storage sites. The object of this characteristic is to increase the safety of the preservation of the haematopoietic-system components collected.
More generally, in the management process according to the invention, the idea of deferred use covers both the field of auto-use in the form, in particular, of auto-injection, use of transfer factor obtained from the lymphocyte collections, or use of monocytes, or use of a culture of lymphocytes with growth factors, such as interleukin II, and the field of use of filiation, in particular in gene therapy, in particular reading of the genetic code and the use of haematopoietic-system components collected from the parents.
The batches of haematopoietic-system components may be re-used, for example, after cell culture in the presence of cell mediators, such as interleukin II, for therapeutic purposes.
According to another aspect of the invention, a system for management of collections of haematopoietic-system components using the process according to the invention is proposed, characterized in that it comprises:
a plurality of centers for collection and packing of batches of haematopoietic-system components,
a plurality of cryogenic storage sites provided to receive the batches of haematopoietic-system components,
a plurality of centers for cell treatment with batches of haematopoietic-system components, and
a center or centers for management of batches of haematopoietic-system components connected by communication means to the collection centers, to the cryogenic storage sites and to the cell treatment centers.
Preferably, the management center or centers cooperate with an express logistics center for forwarding the batches of haematopoietic-system components from the cryogenic storage sites to the cell treatment centers.
Furthermore, the management system according to the invention also comprises means for gathering personal data relating to the patients who have undergone collections of haematopoietic-system components in the plurality of collection centers.
Other details and advantages of the invention will also become apparent in the description below. Regarding the attached drawings, given as non-limiting examples: